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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K142434
Device Name ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
757 "A" ARNOLD DRIVE
MARTINEZ,  CA  94553
Applicant Contact CHRISTINE DUNBAR
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
757 "A" ARNOLD DRIVE
MARTINEZ,  CA  94553
Correspondent Contact CHRISTINE DUNBAR
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/29/2014
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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